Magazine's Investigation of Bioidentical Hormone Therapy Eye-Opening

In looking for relief from menopausal symptoms such as hot flashes and night sweats, are you considering talking to your doctor about the possibility of getting a prescription for bioidentical hormone therapy? Before you do, I’d encourage you to pick up a copy of the October issue of More magazine. This publication, which is focused on issues related to middle-aged and older women, has an eye-opening story on these types of medications that you really need to read.

More commissioned a research group to do lab tests on bioidentical hormones that were produced by 12 compounding pharmacies in the United States. The researchers found that women who use compounded bioidentical hormone therapy may be risking their health. These drugs are often prescribed by doctors to treat women who are perimenopausal and menopausal who are experiencing symptoms such as hot flashes, night sweats and vaginal dryness.

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The study, which was financed in part by the Fund for Investigative Journalism, pointed out that compounding pharmacies are not regulated by the federal government. This decision was based on the limited work that these labs did at the outset. Instead, these labs are regulated by state pharmacy boards. Therefore, these drugs are not required to go through rigorous clinical trials that are required for commercial pharmaceutical companies. More also points out that compounded drugs, which make up approximately 3 percent of the prescriptions filled in the United States, are not subject to the strict manufacturing standards that the U.S. Food and Drug Administration (FDA) requires. Furthermore, these companies are not required to allow FDA inspectors to come into their organizations unless it’s believed that their products are causing illness or death.

So let’s look at this study. A prominent (but unnamed) OB-GYN doctor who is concerned about unregulated hormones provided More’s staff with 12 identical prescriptions for bioidentical hormone therapy known as Tri-Est, which is a combination of progesterone, estradiol, estrone and estriol. Estriol, which is a type of estrogen, has never been approved by the FDA for use in any drug. These prescriptions were filled by 12 different compounding pharmacies. Ten of these pharmacies were online while the other two were actual physical stores.

These filled prescriptions were then provided to Flora Research Laboratories for analysis. The researchers emptied each capsule onto clean weighing paper that was sticky. The researchers then weighed the ingredients. They found that the heaviest weighed 102 milligrams while the lightest weighed 80 milligrams. More points out that this wide variation shows the lack of uniformity in these products.

The researchers then analyzed the ingredients form each capsule using high-performance liquid chromatopgraphy-diode array detection-mass spectrometry. They found that the amounts of ingredients in the different capsules varied tremendously. For instance, estriol ranged from 67.5 percent of the labeled amount in one capsule and 89.5 percent in another. Thus, the researchers found that this particular ingredient was subpotent in these prescriptions.

However, some prescriptions were found to be superpotent. For instance, the estrone ranged from 58.4 percent to 272.5 percent while the estradiol (which is the most potent form of estrogen) ranged from 95.9 percent to 259 percent. The researchers found that the progesterone delivered approximately 80 percent of the prescribed amount. However, one sample had less than 60 percent of the amount that had been prescribed.

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The researchers noted that none of the bioidentical hormone therapy prescriptions that were tested would have passed the requirements established by the FDA for finished drugs that called for the contents to be no less than 90 percent or no more than 110 percent of the prescription that was written by a physician.

There’s much more to the story in More, so do yourself a favor and buy two copies – one for yourself and one for your doctor. I promise you that this will be a wise investment in protecting your health as well as the health of other women.